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European Pharmaceutical Contractor

Data Diligence

Following headlines covering the Facebook and Cambridge Analytica saga, awareness of not only privacy issues, but also the underlying value of data held by corporations and how they are processed has heightened. One area highlighted in this article is how data collected by pharmaceutical companies is underutilised to inform data-driven decisionmaking across the board.

Unlocking Marketing Data

Traditionally, supply chain design and management has focused solely on sourcing products as well as distribution. However, many pharma companies’ supply chains are based on outdated legacy models where high demand and margins were once the norm. With the emergence of generic products, expiring patents, over-the-counter products, and an increased focus on emerging markets to deliver competitiveness, pharma companies need to design and introduce new supply chain models that require new systems, processes, and metrics to be implemented. The definition of supply chain management has broadened over the years, and, in the data-centric world people live in today, supply chain decision makers have begun realising the importance of regulatory, market, and healthcare professional client data, in designing more competitive supply chain models.

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Kieran Bourke at MAXX Design is focused on the development of marketing solutions for pharma companies and has previously worked closely with GSK across its consumer marketing portfolio, helping them to innovate around the rapid rise of mobile marketing. He was previously a spokesperson for the Institute of Practitioners in Advertising.
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Kieran Bourke
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News and Press Releases

BioIVT to Focus on the Application of In Vitro Hepatocyte Models in Toxicology Research at the North American ISSX Meeting

BioIVT, a leading provider of research models and services for drug development, today announced that it will be participating in several sessions at the 22nd North American International Society for the Study of Xenobiotics (ISSX) Meeting. This conference will be held from July 15-19 at the Palais des congrès de Montréal in Montréal, Canada.
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White Papers

Points to Consider When Developing a TMF (Trial Master File) Strategy

Phlexglobal Ltd

Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
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Industry Events

Pharmaceutical Packaging and Device Labelling Europe

11-12 September 2018, Munich, Germany

Relaunching the event after a three year hiatus, Pharma Packaging and Labelling Europe is back to deliver key, actionable insight on the very latest regulatory requirements, technological innovations, strategic developments, and how to implement them into your packaging and labelling chain with both maximum efficiency and minimal cost. The conference is packed with thought provoking innovative discussions.
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